CLASS II ONGOING Device recall · Reported 10 Jul 2024 · FDA Enforcement Report
WOM Tube Set for lrrlgatlon recalled by WOM World Of Medicine AG
WOM World Of Medicine AG is recalling WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the, distributed nationwide in the US. The recall was initiated on 24 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2243-2024
- FDA event ID
- 94749
- Recalling firm
- WOM World Of Medicine AG, Ludwigsstadt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 May 2024
- FDA classified
- 1 Jul 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 24 May 2024 | Recall initiated by company | |
| 1 Jul 2024 | Classified by FDA | +38 days |
| 10 Jul 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Product as listed by the FDA
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the recalled?
Yes. WOM World Of Medicine AG recalled WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the on 24 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2243-2024.
Why was it recalled?
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Which lots are affected?
UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from WOM World Of Medicine AG
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|---|---|---|---|---|---|
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